Diazepam
DIAZEPAM INJECTION, USP
Approved
Approval ID
5993cd06-7ce2-4c7c-9364-f7f66aafc718
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 5, 2023
Manufacturers
FDA
Natco Pharma USA LLC
DUNS: 079590418
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIAZEPAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69339-137
Application NumberANDA211998
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIAZEPAM
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateOctober 6, 2022
FDA Product Classification
INGREDIENTS (6)
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DIAZEPAMActive
Quantity: 5 mg in 1 mL
Code: Q3JTX2Q7TU
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT